HI-Light Pilot Trial for Vitiligo: Hand Held NB-UVB for Early or Focal Vitiligo at Home

Summary

This study is a small pilot randomised controlled trial (RCT) comparing hand-held NB-UVB light devices with placebo devices. These devices will be used by the participants to treat their vitiligo at home for a period of four months. The main purpose of the trial is to provide feasibility data that can be used to inform the design of a future multi-centre RCT of these devices. Two hand-held UVB devices with similar manual operating system are being tested during this pilot study. This trial will help the investigators to establish which device is likely to be best for the main trial.

Participants will be approached in a variety of ways (through secondary care, primary care and through direct advertising). Potential participants who contact the co-ordinating centre expressing an interest in the trial will be given more information about the trial, checked for preliminary eligibility, and sent an appointment for a screening visit at the closest recruiting hospital (Nottingham or Leicester).

This screening visit will be conducted by a research nurse, but a dermatologist will also be present in order to confirm the diagnosis of vitiligo and to confirm the participant's suitability for UVB treatment at home. If eligible and willing to take part in the trial, participants will provide written informed consent and baseline data will be collected. In order to define the starting dose to be used when treating the vitiligo, a minimum erythema dose (MED) test will be conducted.

An educational session will be provided by the research nurse outlining how to use the devices, how to assess side-effects of the treatment and how to complete the treatment diary. It is anticipated that the screening visit and educational session will take place on the same day and may take up to 1.5 hours.

On the following day, a brief visit to the hospital will be required in order to examine the skin and read the MED results (if more convenient, the educational session may be delivered at this time). Once this has been done, participants will be given the devices to use at home - treatment is applied 3 times per week on alternate days. They will be followed up by telephone at week 1, week 2 and week 12 - in order to provide support and to monitor side-effects. Participants will be asked to keep a treatment diary that records when the treatment has been used and records side-effects experienced. Emergency contact details will be provided in case of urgent medical need.

Participants will continue with treatment at home for the 16-week trial period. Two further hospital visits will take place in order to record outcome data

Conditions

• Vitiligo

Interventions

DEVICE

311 nm NB-UVB light

Narrowband UVB is now the most common form of phototherapy used to treat skin diseases. Narrow-band refers to a specific wavelength of ultraviolet (UV) radiation, 311 to 312 nm. Hospital NB-UVB usually involves whole body cabinets suitable for extensive, generalised vitiligo i.e. large or multiple lesions. Usually the whole body is exposed to the UVB for a short time (seconds to minutes). NB-UVB is also used in the treatment of many other skin conditions including psoriasis and eczema. Hand held phototherapy units use the same lamp as the whole body units (TLO1) but only suitable for the treatment of smaller areas of skin i.e. early and focal lesions of vitiligo. Early reports showed that these units are also safe and effective for the treatment of psoriasis of the scalp.

Sponsors & Collaborators

• University of Nottingham

  lead OTHER

Principal Investigators

• Hywel C. Williams, MSc PhD FRCP · Centre of Evidence Based Dermatology

• Viktoria Eleftheriadou, MD · Centre of Evidence Based Dermatology

• Jane C Ravenscroft, MB ChB, MRCP · Queen's Medical Center

• Anton Alexandroff, PhD MRCP · University Hospitals, Leicester

Study Design

Allocation

RANDOMIZED

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2012-09-30

Completion

2013-04-30

Countries

• United Kingdom

Study Locations